Role of Exercise in PRISm and Subsequent Development of COPD

NCT07387432 | Recruiting DMC

• 1 other identifier: UW 24-461
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Preserved Ratio Impaired Spirometry (PRISm) describes individual with spirometry findings of forced expiratory volume (FEV1) and forced vital capacity (FVC) ratio greater than 0.7 but with the FEV1 less than 80% predicted. While the spirometry findings of individuals with PRISm can be transited into obstructive pattern, remains at PRISm or become normal spirometry, limited evidence is on the role of exercise in the course of PRISm. This study aims to investigate the role of exercise, namely exercise with telehealth and walking exercise, together with smoking cessation advice, would alter the clinical course of PRISm.

Conditions

Preserved Ratio Impaired Spirometry (PRISM)

Keywords

Preserved ratio impaired spirometry; PRISm; exercise with telehealth; walking exercise; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Change in 6 minute walk test distance

  The 6 minute walk test distance will be measured in the start of the study, at 3 months, 6 months and 12 months. The differences will be compared.

  1 year

Study Arms (3)

Exercise with telehealth group

EXPERIMENTAL

Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.

Behavioral: Exercise with telehealth group

Exercise group

ACTIVE COMPARATOR

Participants will exercise with walking. Smoking cessation advice will be given.

Behavioral: Exercise group

No exercise group

ACTIVE COMPARATOR

No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.

Behavioral: No exercise group

Interventions

No exercise group BEHAVIORAL

No exercise instruction will be given. Participants are encouraged to exercise. Smoking cessation advice will be given.

No exercise group

Exercise with telehealth group BEHAVIORAL

Participants will attend telehealth physiotherapy class for exercise. Smoking cessation advice will be given.

Exercise with telehealth group

Exercise group BEHAVIORAL

Participants will exercise with walking. Smoking cessation advice will be given.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above
• Smoker/ ex-smoker
• Spirometry shows PRISm, with FEV1/FVC \>= 0.7 and FEV1 \<80% predicted
• Ambulatory to walk
• Able to give informed consent

You may not qualify if:

• Age below 18
• Non-smoker
• Spirometry does not show PRISm/ unable to perform spirometry
• Requires assistance for walking
• Unable to give informed consent

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, China

RECRUITING

Related Publications (4)

• Hansen H, Bieler T, Beyer N, Kallemose T, Wilcke JT, Ostergaard LM, Frost Andeassen H, Martinez G, Lavesen M, Frolich A, Godtfredsen NS. Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial. Thorax. 2020 May;75(5):413-421. doi: 10.1136/thoraxjnl-2019-214246. Epub 2020 Mar 30.

  PMID: 32229541 BACKGROUND

• Wan ES, Balte P, Schwartz JE, Bhatt SP, Cassano PA, Couper D, Daviglus ML, Dransfield MT, Gharib SA, Jacobs DR Jr, Kalhan R, London SJ, Navas-Acien A, O'Connor GT, Sanders JL, Smith BM, White W, Yende S, Oelsner EC. Association Between Preserved Ratio Impaired Spirometry and Clinical Outcomes in US Adults. JAMA. 2021 Dec 14;326(22):2287-2298. doi: 10.1001/jama.2021.20939.

  PMID: 34905031 BACKGROUND

• Perez-Padilla R, Montes de Oca M, Thirion-Romero I, Wehrmeister FC, Lopez MV, Valdivia G, Jardim JR, Muino A, B Menezes AM; PLATINO Group. Trajectories of Spirometric Patterns, Obstructive and PRISm, in a Population-Based Cohort in Latin America. Int J Chron Obstruct Pulmon Dis. 2023 Jun 21;18:1277-1285. doi: 10.2147/COPD.S406208. eCollection 2023.

  PMID: 37366430 BACKGROUND

• Holland AE, Cox NS, Houchen-Wolloff L, Rochester CL, Garvey C, ZuWallack R, Nici L, Limberg T, Lareau SC, Yawn BP, Galwicki M, Troosters T, Steiner M, Casaburi R, Clini E, Goldstein RS, Singh SJ. Defining Modern Pulmonary Rehabilitation. An Official American Thoracic Society Workshop Report. Ann Am Thorac Soc. 2021 May;18(5):e12-e29. doi: 10.1513/AnnalsATS.202102-146ST.

  PMID: 33929307 BACKGROUND

Related Links

• Global Initiative for Chronic Obstructive Lung Disease (GOLD) report. GOLD works with health care professionals and public health officials to raise awareness of Chronic Obstructive Pulmonary Disease (COPD).

MeSH Terms

Conditions

Smoking Cessation

Interventions

Exercise

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• King Pui Florence Chan, MD

  he University of Hong Kong, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

King Pui Florence Chan, MD

CONTACT

+852 22553741; kpfchan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: July 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)